Tag Archive for: clinical trial eligibility

Questions to Ask About Endometrial Cancer Clinical Trials

 

What questions should patients ask about endometrial cancer clinical trials? Dr. Hinchcliff outlines key inquiries regarding trial structure and eligibility and encourages patients to explore online resources and support groups for additional information.

Dr. Emily Hinchcliff is a Gynecologic Oncologist at Northwestern Medicine. Learn more about Dr. Hinchcliff.

 

Related Programs:

Current Endometrial Cancer Treatment Approaches
Advances in Endometrial Cancer Treatment and Research
Where Do Clinical Trials Fit Into an Endometrial Cancer Plan?

Where Do Clinical Trials Fit Into an Endometrial Cancer Plan?


Transcript:

Katherine Banwell:  

What questions should endometrial cancer patients ask their doctor about a potential trial? 

Dr. Emily Hinchcliff:  

I think the two important things to ask are what is the structure, what am I actually going to get, or what could I get, depending on how many of those arms exist on the trial. 

Katherine Banwell:  

Would the doctor know that specific information, though? 

Dr. Emily Hinchcliff:  

It’s a good question, actually. So, generally speaking, most of us as physicians, in order to offer a trial to you, we have an overarching structure of that clinical trial. There may be some nuances about what the exact enrollment is in terms of the majority of the patients get this treatment, whereas a small minority get this treatment, or because of this patient’s specific mutation profile, they must be enrolled on this subset of the trial. 

So, there are some nuances there that, generally speaking, if I as the physician don’t know, I will contact what’s called my clinical trial coordinator or my research nurse, and they can come spell out some of those nuances, but if your doctor’s recommending a trial to you, they generally know what is the overarching goal, and what is the overarching treatment being tested. 

Katherine Banwell:  

Okay. How can patients learn more about clinical trials? 

Dr. Emily Hinchcliff:  

So, there are a lot of resources online. To some extent, it can be really overwhelming for patients to try and tease out am I a candidate, would I be eligible for a trial, or this trial, is this trial available at my institution. So, what I would say – first and foremost, ask your physician. I think that your physician is your advocate in this and your partner in your cancer care, and I think that certainly I and all of us as physicians feel really strongly that we can help you weigh those different options as you see them and as we learn about them.  

So, I think that that’s where I would start. I think there are a lot of online resources. The FDA and the government have a cancer trials website that you can go to and search for your specific cancer type. 

Many institutions – my own included – will have their own institutional trials website, where, on my institution, you can look up and see what trials do we have open on my institution, because obviously, the government will speak nationally, but your particular treating physician might not have the availability to give you that particular trial. And then, I also will say I think patient support groups are an incredible opportunity to understand what others have been going through and what treatments have been offered, and that can be a really helpful resource as well to get hooked into as a patient is trying to tease all this out. 

AML Clinical Trials | When to Consider This Treatment Option

 

How do clinical trials fit into an AML treatment plan? Dr. Eric Winer highlights the importance of clinical trials to advancing AML therapies and encourages discussing your options and trial eligibility with your care team. 

Dr. Eric S. Winer is Assistant Professor of Medicine at Harvard Medical School and Clinical Director of Adult Leukemia at Dana-Farber Cancer Institute. Learn more about Dr. Winer.

 
Related Resources:
Emerging AML Treatment Options | Inhibitor Therapies

Emerging AML Treatment Options | Inhibitor Therapies

Elevate | Expert Advice for Accessing Quality AML Care and Treatment

Elevate | Expert Advice for Accessing Quality AML Care and Treatment

Elevate | What You Should Know About Your Role in AML Treatment and Care Decisions

Elevate | What You Should Know About Your Role in AML Treatment and Care Decisions 

Transcript: 

Katherine Banwell:

When considering treatment options, where do clinical trials fit into the plan? 

Dr. Eric Winer:

I think clinical trials are extraordinarily important. The way that I think many of us think about this is we want to continually do better, and have our patients continually have improvements. The only way we can do that is by bringing forth novel medications in order to gain that extra improvement. As mentioned, all of these small molecule inhibitors, every drug that we have out there, started off as clinical trials.   

We were able to gain benefit, and patients are able to gain benefit by taking part in these clinical trials. Not all clinical trial is successful to be fair, and different types of clinical trials have different scientific knowledge beforehand. For example, Phase I clinical trials tend to be more experimental. We don’t know as much about the drugs.  

Phase III experimental clinical trials are much more well-known. Then there are a bunch in between in terms of Phase I’s where we know the drug, but we’re studying more of a combination, but of these clinical trials, the purpose of this is to gain benefit.  

If we didn’t have a drug that we believed was going to be helpful, we wouldn’t be doing that clinical trial. So, while some people may think of these things as experimental, I think of them as rationally evaluating a way to target particular forms of leukemia to gain better responses. 

Katherine Banwell:

If a clinical trial isn’t offered, how can patients inquire about their potential options? 

Dr. Eric Winer:

The first thing to do is speak to their physician. Many physicians, if they have clinical trials, they’ll know the eligibility. They’ll know who is and isn’t eligible, and why they’re not eligible. That’s something that can be easily explained to people. The second thing is if there aren’t clinical trials available at that institution, then it’s important for the patients to talk to their clinicians, and say, is there a clinical trial available someplace else that might be good for me.  

Many of us field calls from other physicians, from other colleagues, who call us and say, “Hey, I have a patient with this particular disease. Do you have a clinical trial available?” We’re always willing to collaborate. The one nice thing about the leukemia field is it’s a relatively small field. We all know each other. We all realize that the purpose of this is to make patients better. And so, we all share information, and we all work together to try to get that accomplished. 

Katherine Banwell:

There are a couple of really good websites available too, to find out about clinical trials, correct? 

Dr. Eric Winer:

There are, and I think that by contacting different institutions that can be helpful, such as the Leukemia & Lymphoma Society is a good one. There is a national clinical trial database called clinicaltrials.gov.  

Those are all very important, but sometimes they can be a little difficult to navigate. And so, it’s always good to go back to your physician or your physician team and discuss these things to make sure that the clinical trial that someone is looking at is actually an applicable clinical trial for them.  

Advice for Shared Decision-Making | Myelofibrosis Care and Treatment Goals

Myelofibrosis expert Dr. Naveen Pemmaraju advises on how patients and healthcare teams can partner together by communicating care goals and exploring treatment options.

Dr. Naveen Pemmaraju is Director of the Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Program and Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center. Learn more about Dr. Pemmaraju.

Download Resource Guide

See More from Elevate Myelofibrosis

Related Resources:

What Myelofibrosis Treatment Types Are Available?

What Myelofibrosis Treatment Types Are Available?

Myelofibrosis Symptoms and Side Effects | Why Speaking Up Is Vital

Myelofibrosis Symptoms and Side Effects | Why Speaking Up Is Vital

Emotional Health | Why It’s Vital for Myelofibrosis Patients to Share Concerns 

Emotional Health | Why It’s Vital for Myelofibrosis Patients to Share Concerns

Transcript:

Katherine Banwell:

When it comes to choosing therapy, Dr. Pemmaraju, it’s important to work with your healthcare team to identify what is going to work best for you. So, as a clinician, how do you define shared decision-making?  

Dr. Naveen Pemmaraju:

Very important. So, shared decision-making to me means a partnership. It means a journey that the patient and the providing team are about to embark on. It’s a very different approach than a one-way, I tell you, you do this. Instead, I see it as a bi-directional exchange of ideas.  

Each visit, each EPIC in-basket or EMR communication, each touch with the healthcare system, the pharmacist, the PA, nurse, whoever is dealing with the patient, I think that’s the key.  

So, a bi-directional exchange of ideas, what’s important to you as the patient? What’s important to the caregiver? What are the worries? What are the barriers? Designing a treatment system around that, a treatment paradigm and approach. Discussing risks, benefits, side effects, toxicities, alternatives, and then a constant dynamic reevaluation throughout. That’s what I pictured. It has to be a journey and a partnership.  

Katherine Banwell:

Well, part of making care decisions is setting goals, and I think you’ve just alluded to that. What are treatment goals for myelofibrosis, and how are they determined?  

Dr. Naveen Pemmaraju:

That’s a great question. Myelofibrosis treatment goals are changing in real-time. I would say as of this recording, 2024, the main three things that I want patients to think about and the caregivers.  

Number one is a stem-cell transplant eligible or not? It used to be based on age and comorbidities, but there are other factors. So, are we going to stem cell transplants or not? That determines a lot of the journey. Two is a clinical trial or not. So, are we doing the standard of care therapy, often one pill at a time, or clinical trial, either an IV drug, a pill, or combinations? Then three is that dynamic assessment that we talked about, which is what are the goals of care? Often our patients with myelofibrosis have decreased quality of life, enlarged organs, fatigue, cachexia, and malnutrition.  

These are the central components. A lot of times they’re due to the myelofibrosis itself. So, the treatments may improve that. A lot of times it’s the other comorbidities, other health issues. So, working with the PCP, the primary care provider, and the local team. In my case, many of my patients are referrals, as you know, the local MD team. I think these are the three components, transplant eligibility or not, clinical trial versus standard of care. 

Then once we’ve made a treatment decision, minding toxicities and quality of life.  

Advice for Inquiring About Myeloma CAR T-Cell Therapy Clinical Trials

How can patients find CAR T-cell therapy clinical trials? Nurse practitioner Donna Catamero shares resources for identifying trials, such as ClinicalTrials.gov, and encourages patients to ask providers about available trials and eligibility.

Donna Catamero is a Nurse Practitioner and associate director of the Multiple Myeloma Clinical Research Program at Mount Sinai Hospital in New York City. Learn more about Donna Catamero.

Related Resources:

Understanding Myeloma Therapy Targets BCMA and GPRC5D

Understanding Myeloma Therapy Targets BCMA and GPRC5D

How Is CAR T-Cell Therapy Research Advancing Myeloma Care?

How Is CAR T-Cell Therapy Research Advancing Myeloma Care?

How Can Myeloma Patients Access CAR T-Cell Therapy Clinical Trials?

How Can Myeloma Patients Access CAR T-Cell Therapy Clinical Trials?

Transcript:

Katherine Banwell:

How can patients find CAR T clinical trials that might be right for them? 

Donna Catamero:

So, ClinicalTrials.gov can point patients in the right direction. Again, the foundations – the Multiple Myeloma Research Foundation, the International Myeloma Foundation – can help direct patients toward clinical trials that might be right for them.  

Katherine Banwell:

How can patients start the conversation with their provider? What questions should they be asking about trials? 

Donna Catamero:

So, first, when you’re given options for treatment, you should always ask – always, always ask – “Am I eligible for a clinical trial?” 

All the therapies we have available today for patients initially came from clinical trials. In our early CAR T therapies, those patients had access to those drugs years before the general myeloma population, so clinical trials are key to really moving the therapies for tomorrow.  

Understanding Common Clinical Trial Terminology

Medical terminology can be confusing and is especially important to understand when reviewing information to learn about a clinical trial. Dr. Pauline Funchain of Cleveland Clinic explains common terms and phrases to help patients better understand the clinical trial process.
 
Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.

Katherine Banwell:

Dr. Funchain, are there common clinical trial terms that patients should know? 

Dr. Pauline Funchain:

Yeah, there are trial terms that people hear all the time, and probably should know a little bit about. But I think the most common thing people will hear with trials are the type of trial it is, so Phase I, Phase II, Phase III. The important things to know about that are essentially, Phase I is it’s a brand-new drug, and all we’re trying to do is look for toxicity. Although we’ll always on the side be looking for efficacy for whether that drug actually works, we’re really looking to see if the drug is safe. 

A Phase II trial is a trial where we’re starting to look at efficacy to some degree, and we are still looking at toxicity. And then in Phase III is, we totally understand the toxicity, and we are seeing promise, and what we really want to do is see if this should become a new standard. So, that would be the Phase I, II, and III. 

Another couple of terms that people hear a lot about are eligibility criteria, or inclusion criteria. So, those are usually some set of 10 to 30 things that people can and can’t be. So, usually trials only allow certain types of cancer, and so that would be an inclusion criteria, but it will exclude other types of cancers. Most trials, unfortunately, exclude pregnant women. That would be an exclusion criteria.  

So, these are things that, at the very beginning of a trial, will allow someone to enter, or say, “You’re not in the safe category, we should not put you on a trial.” Many trials are randomized, so people will hear this a lot. Randomization.  

So, a lot of times, there is already a standard of care. When there’s already a standard of care, and you want to see if this drug is at least the same or better, then on that trial, there will be two different arms; a standard of care arm and experimental arm.  

And then in order to be fair, a randomized trial is a flip of a coin. Based on a electronic flip of a coin – nobody gets to choose; not the doc, not the patient. On that type of trial, you’ll either get what you would normally get, standard of care, or something new. So, that’s a randomized trial. Not all trials are randomized, but some are. And those are the things that people will run into often.